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Sponsored by: |
Human Genome Sciences |
Information provided by: | Human Genome Sciences |
ClinicalTrials.gov Identifier: | NCT00583362 |
This is a continuation study to evaluate the long-term safety and efficacy of LymphoStat-B™ in subjects with SLE disease, that completed study LBSL02 and benefitted from treatment.
Condition | Intervention | Phase |
Systemic Lupus Erythematosus |
Drug: belimumab |
Phase II |
MedlinePlus related topics: | Lupus |
Drug Information available for: | Belimumab |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Multi-Center, Open-Label, Continuation Trial LymphoStat-B™ Antibody (Monoclonal Anti-BLyS Antibody) in Subjects With Systemic Lupus Erythematosus (SLE) Who Completed the Phase 2 Protocol LBSL02 |
Enrollment: | 298 |
Study Start Date: | May 2005 |
Estimated Study Completion Date: | September 2010 |
Estimated Primary Completion Date: | September 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
1: Experimental |
Drug: belimumab
IV 10mg/kg Q28 days
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The purpose of this continuation study to evaluate the long-term safety and efficacy of LymphoStat-B™ in subjects with Systemic Lupus Erythematosus (SLE), that completed study LBSL02 and benefitted from treatment.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Primary Inclusion Criteria
1. Have completed the LBSL02 trial and achieved a satisfactory response.
Primary Exclusion Criteria
Used any of the following prohibited medications during their participation in LBSL02:
Show 61 Study Locations |
Human Genome Sciences |
Study Director: | William Freimuth, MD, PhD | Human Genome Sciences, Inc. |
Responsible Party: | Human Genome Sciences, Inc. ( William Freimuth, MD, PhD/Vice President of Clinical Research, Immunology, Rheumatology and Infectious Diseases ) |
Study ID Numbers: | LBSL99 |
First Received: | December 20, 2007 |
Last Updated: | April 9, 2008 |
ClinicalTrials.gov Identifier: | NCT00583362 |
Health Authority: | United States: Food and Drug Administration; Canada: Health Canada |
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